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Neuropsychological Consultation as Part of Pediatric Diabetes Care: Does it Improve Glycemic Control and Family Functioning? 50 無作為化 小児 非盲検

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治験(臨床試験)の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします!「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT03653013 は 介入研究 臨床試験 で、糖尿病、Glycinemia を対象とした研究でした。現在は 完了 です。2019年7月16日 に開始し、50 名の参加者 が参加しました。この試験は NYU Langone Health によって主導され、2023年8月1日 に完了しました。ClinicalTrials.gov からの最新更新日は 2023年8月24日 です。
概要
This is a randomized controlled open label study design (study team will not be blinded) to measure whether including targeted neuropsychological consultations as part of pediatric diabetes care informs treatment and educational planning, improves glycemic control, and improves quality of life. Patients will be randomized 1:1 ratio to Group 1-Control group and Group 2-Neuropsychological consultation group.
公式タイトル

Neuropsychological Consultation as Part of Pediatric Diabetes Care: Does it Improve Glycemic Control and Family Functioning?

疾患名
糖尿病Glycinemia
その他の研究識別子
  • 18-00649
NCT番号
開始日
2019-07-16
最終更新日
2023-08-24
終了予定日
2023-08-01
目標参加者数
50
試験の種類
介入研究
治験の相・段階
該当なし
状況
完了
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
なし(非盲検)
群(アーム)/介入
参加グループ/群介入/治療法
実薬対照薬Control Group
Usual standard of care from their diabetes care team
Usual standard of care
Participants will receive treatment and diabetes management as usual standard of care from their diabetes care team. They will also complete as part of the study visit: a pediatric quality of life scale(PedsQL,GenericScale and Diabetes Module) and diabetes related family conflict scale (DFCS-R) to assess quality of life and family stress at the start of the study.
実験的Neuropsychological Consultation Group
Children will be administered a number of neuropsychological tests. Children and parents in Group 2 will also complete a pediatric quality of life scale (PedsQL, Generic Scale and Diabetes Module), diabetes related family conflict scale (DFCS-R) to assess quality of life and family stress at the start of the study, as well as the self-report form of the BRIEF-2 if they are over age 11. Parents will also undergo a bri...もっと見る
Neuropsychological Consultation
Children and parents in Group 2 will also complete a pediatric quality of life scale (PedsQL,Generic Scale and Diabetes Module),diabetes related family conflict scale (DFCS-R) to assess quality of life and family stress at the start of the study, as well as the self-report form of the BRIEF-2 if they are over age 11. Parents will also undergo a brief literacy and numeracy screening using the Wide Range Achievement Te...もっと見る
主要評価項目
評価指標指標の説明時間枠
Improved Glycemic Control measured by assessment of glycemic control (HgbA1C)
0 Months
Improved Glycemic Control measured by assessment of glycemic control (HgbA1C)
3 Months
Improved Glycemic Control measured by assessment of glycemic control (HgbA1C)
6 Months
Improved Glycemic Control measured by assessment of glycemic control (HgbA1C)
9 Months
適格基準

対象年齢
小児, 成人
試験の最低年齢
10 Years
対象性別
全て
  • diagnosed with type 1 diabetes and followed for their care at the NYU pediatric diabetes center
  • English speaking families

  • not english speaking
  • diagnosed with type 1 diabetes within the last 6 months
NYU Langone Health logoNYU Langone Health
連絡先情報がありません。
1 1カ国の場所

New York

NYU Langone Health, New York, New York, 10016, United States